FACTS® (FDA Approval Consulting and Training Services)

Cindy Hoffman of MediaMentors has drawn from her decades of experience in all aspects of healthcare communication to develop FACTS® (FDA Approval Consulting and Training Services) to address the needs of businesses before, during, and after a drug or medical device’s evaluation.

These services help representatives of pharmaceutical, biotech, diagnostic, and medical device companies handle communications in every phase of the FDA approval process, whether addressing government regulators, scientists or physicians, the public, or the media.

MediaMentors has helped representatives of pharmaceutical and biotech companies speak with clarity, credibility, and authority while managing issues related to new drug launches, clinical trials, drug safety, Rx to over-the-counter switches, new indications, blackbox warnings, “Dear Doctor” letters, and advisory committee hearings.

FACTS® includes four components which are offered individually or as part of a complete communications package:

• Presentation strategy. MediaMentors works with the medical, clinical, regulatory, legal and commercial teams to develop and refine the story and the messages and perfect the content, structure, and flow.
• Speaker coaching. MediaMentors can help identify presenters, select the presentation format, and ensure that voice, body language, and delivery support the communication goals.
• Q and A preparation. Successfully handling the Q and A process is critical to obtaining FDA approvals. MediaMentors helps create a Q and A document targeting the probable questions expected on hot-button issues of both supporters and detractors on the advisory committee. It then teaches the speakers the skills needed to handle the most difficult questions with credibility and authority.
• Dealing with outside parties. Finally, spokespersons are trained to deal with the media, analysts, and other third-parties with finesse.

As part of the FACTS® program, MediaMentors can partner with other firms and assist with slide preparation, advisory committee meeting logistics, and the gathering of competitive intelligence.

Contact us to learn more about how FACTS® can help protect, promote, and enhance your company’s reputation, and optimize its investment in research, development, and marketing.